On June 5th, the Food and Drug Administration (FDA) published a press release about how they recently issued an online opioid supplier warning to nine online networks comprised of 53 different websites about illegally marketing misbranded, unapproved and potentially dangerous versions of oxycodone, tramadol, and other opioid medications. According to the FDA, those that fail to comply with correcting the violations outlined in their online opioid supplier warning letters could be subjected to an injunction, product seizure or other enforcement action.
The FDA says they’re taking additional steps to protect consumers by targeting websites that are illegally marketing illicit opioids and other illicit drugs. The agency will begin working with legitimate internet firms interested in voluntarily cracking down on the illegal sales. The FDA will host a summit to collaborate with internet stakeholders about potential solutions while continuing to take action against websites and firms deliberately breaking the law.
The FDA commissioner contends that the illegal online marketing of unapproved opioids is a contributing factor to the national opioid crisis. The FDA claims that the letters are a warning to the network operators that marketing unapproved opioids to consumers will not go unchallenged. The misbranded and unapproved opioids may be counterfeit and potentially contain dangerous substances that endanger consumers lives. These warnings letters are the hallmark of the comprehensive FDA campaign being launched to target these illegal sales.
The FDA plans on following up with additional actions over the coming months. Aside from being potentially counterfeit, these unapproved opioids may also be expired, contaminated or unsafe in other ways. According to the agency, the network and website operators involved in the illegal marketing of misbranded and unapproved opioids are in violation of the Federal Food, Drug, and Cosmetic Act.
The illegal marketing is especially concerning since oxycodone and tramadol carry a boxed warning, the agency’s most prominent warning. These products receive boxed warnings due to risks related to addiction and life-threatening adverse effects like respiration depression. The networks that have received the warning include AnonShop, Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart
RxCash.Biz, TramadolHub, and XLPharmacy.
FDA officials say the public needs to understand that with or without a prescription, no one has the authority to sell or distribute opioids in the U.S. over the internet. According to the agency, rogue website operators and drug dealers are using the internet to fuel the opioid crisis and victimized people suffering from opioid use disorder. The warning issued by the FDA requests the companies respond within 10 business days to identify the specific actions taken to address violations.
The agency considers the opioid addiction in the US to be an immense public health crisis one of its highest priorities. Because the risk of detection can be lower for drug dealers on the internet, officials are focused on getting internet stakeholders to be more proactive about cracking down on internet traffic dealing in with illicit drugs.
On June 27, the FDA will host academic researchers, advocacy groups, internet stakeholders and government entities at the Online Opioid Summit to discuss ways to reduce the availability of opioids online. The summit will include a roundtable discussion about new solutions and existing gaps, research on how easy it is to obtain illicit opioids online and industry approaches to addressing when opioids are being marketed online.
Aside from the health risks, the FDA says illegal online pharmacies can also endanger consumers through computer viruses, identity theft, and credit card fraud. The agency concluded the press release reiterating its commitment to addressing the national opioid crisis on every front, including focusing on preventing new addiction, reducing opioid exposure, supporting new treatments and therapies and taking action against those involved in illegal opioid activity.
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